title: Human rotavirus vaccine is highly efficacious when coadministered with routine expanded program of immunization vaccines including oral poliovirus vaccine in Latin America.
abstract: BACKGROUND
  The efficacy of a rotavirus vaccine against severe rotavirus gastroenteritis when coadministered with routine Expanded Program on Immunization (EPI) vaccines including oral polio vaccine (OPV) was evaluated in this study.
  
  
  METHODS
  Double-blind, randomized (2:1), placebo-controlled study conducted across 6 Latin American countries. Healthy infants (N = 6568) 6 to 12 weeks of age received 2 doses of RIX4414 vaccine or placebo following a 0, 1- to 2-month schedule. Routine vaccines including OPV were coadministered according to local EPI schedule. Vaccine efficacy (VE) against severe rotavirus gastroenteritis caused by circulating wild-type rotavirus from 2 weeks post-Dose 2 until 1 year of age was calculated with 95% confidence interval [CI]. Safety was assessed during the entire study period. Immunogenicity of RIX4414 and OPV was also assessed.
  
  
  RESULTS
  During the efficacy follow-up period (mean duration = 7.4 months), 7 and 19 cases of severe rotavirus gastroenteritis were reported in the vaccine and placebo groups, respectively, with a VE of 81.6% (95% CI: 54.4-93.5). VE against severe rotavirus gastroenteritis caused by G1 type was 100% (95% CI: <0-100) and 80.6% (95% CI: 51.4-93.2) against the pooled non-G1 rotavirus types, respectively. There was no difference (P = 0.514) in the incidence of serious adverse events reported in the 2 groups. Antirotavirus IgA seropositivity rate at 1 to 2 months post-Dose 2 was 61.4% (95% CI: 53.7-68.6) in the RIX4414 group; similar seroprotection rates (≥96.0%) against the 3 antipoliovirus types was observed 1 month post-Dose 3 of OPV in both groups.
  
  
  CONCLUSIONS
  RIX4414 was highly efficacious against severe rotavirus gastroenteritis caused by the circulating wild-type rotavirus (G1 and non-G1) when coadministered with routine EPI vaccines including OPV.
authors.affiliation: CEDEPAP, Córdoba, Argentina.
authors.forename: Miguel W
authors.initials: MW
authors.lastname: Tregnaghi
authors.forename: Héctor J
authors.initials: HJ
authors.lastname: Abate
authors.forename: Alejandra
authors.initials: A
authors.lastname: Valencia
authors.forename: Pio
authors.initials: P
authors.lastname: Lopez
authors.forename: Themis Reverbel
authors.initials: TR
authors.lastname: Da Silveira
authors.forename: Luis
authors.initials: L
authors.lastname: Rivera
authors.forename: Doris Maribel
authors.initials: DM
authors.lastname: Rivera Medina
authors.forename: Xavier
authors.initials: X
authors.lastname: Saez-Llorens
authors.forename: Silvia Elena
authors.initials: SE
authors.lastname: Gonzalez Ayala
authors.forename: Tirza
authors.initials: T
authors.lastname: De León
authors.forename: Leen-Jan
authors.initials: LJ
authors.lastname: Van Doorn
authors.forename: Maria Del
authors.initials: MD
authors.lastname: Pilar Rubio
authors.forename: Pemmaraju Venkata
authors.initials: PV
authors.lastname: Suryakiran
authors.forename: Javier M
authors.initials: JM
authors.lastname: Casellas
authors.forename: Eduardo
authors.initials: E
authors.lastname: Ortega-Barria
authors.forename: Igor V
authors.initials: IV
authors.lastname: Smolenov
authors.forename: Htay-Htay
authors.initials: HH
authors.lastname: Han
mesh_terms: D004311:Double-Blind Method; D005260:Female; D005759:Gastroenteritis / Q000517:prevention & control*; D006801:Humans; D007114:Immunization / Q000009:adverse effects / Q000379:methods*; D007115:Immunization Schedule; D007223:Infant; D007843:Latin America; D008297:Male; D010919:Placebos / Q000008:administration & dosage; D011055:Poliovirus Vaccine, Oral / Q000008:administration & dosage; D012400:Rotavirus Infections / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D010919:Placebos; D011055:Poliovirus Vaccine, Oral; C492457:RIX4414 vaccine; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated